Objective: To evaluate the long-term safety and tolerability of subthalamic nucleus deep brain stimulation (DBS) for early stage Parkinson’s disease (PD).

Background: Twenty-nine subjects with early stage PD were randomized to receive Optimal Drug Therapy (ODT) or DBS and ODT (DBS+ODT) and completed a two-year pilot trial (NCT#00282152). Subjects were followed for three additional years to gather longitudinal outcomes. PD medications were managed by the referring neurologist (not the principal investigator). During follow-up, four subjects randomized to the ODT group elected to receive standard-of-care DBS.

Methods: We analyzed levodopa-equivalent daily dose (LEDD) of PD medication [1] and adverse events (AEs). Within-subjects change in LEDD from baseline to five years was analyzed using Wilcoxon signed rank tests in an intention-to-treat (ITT) analysis and a censored analysis excluding data collected from subjects in the ODT group after they received DBS. AEs were collected prospectively; AEs that occurred between years two and five were included in this analysis.

Results: In the ITT analysis, LEDD did not change from baseline to 5 years in the DBS group (409±316mg to 774±590mg, p=0.10) but increased significantly in the ODT group (491±216mg to 1158±678mg, p=0.003). The censored analysis confirmed these findings in the ODT group (466±240mg to 1151±515mg, p=0.007). A total of 134 AEs were identified: 66 in the DBS+ODT group, 50 in the ODT group, and 18 in the ODT group after DBS surgery. Five of the 134 AEs were related to the surgery or device: three in ODT subjects who received DBS during follow-up (cognitive disorder, confusional state, pneumocephalus) and two in the DBS group (post-procedural hematoma, medical device site scar). Of 13 study-related AEs, the most common was nausea (n=2 in DBS+ODT, n=1 in ODT). Of 116 unrelated AEs, the most common was depression (n=3 in DBS+ODT, n=3 in ODT).

Conclusions: Medication requirements remained stable five years after DBS but increased significantly in the ODT group. Furthermore, this analysis suggests that DBS in early PD has a favorable long-term safety profile. The FDA has approved (IDE#G050016) a prospective, double-blind, placebo-controlled pivotal trial testing DBS in early stage PD in 280 subjects at 18 centers.

References: Reference: [1] Tomlinson et al. Mov Disord. 2010; 25: 2649-53.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/safety-and-tolerability-of-deep-brain-stimulation-in-early-stage-parkinsons-disease-five-year-follow-up-of-medication-use-and-adverse-events/